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JACTAX LD Drug Eluting Stent Trial

This study has been completed.
Sponsor:
Collaborator:
Labcoat, Ltd.
Information provided by:
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT00754975
First received: September 16, 2008
Last updated: August 5, 2010
Last verified: August 2010
  Purpose

Prospective, multi-center, randomized trial. A maximum of 130 patients will be enrolled, in a 2:1 ratio to receive either the JACTAX LD stent or the TAXUS™ Libertè™ stent to evaluate the efficacy of the product.


Condition Intervention
Coronary Artery Disease
Device: JACTAX LD DES
Device: TAXUS™ Libertè™ DES

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Clinical Trial Comparing the Performance of the JACTAX LD DES With the TAXUS™ Libertè™ DES

Further study details as provided by Boston Scientific Corporation:

Primary Outcome Measures:
  • MACE rate at 9 months [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]

Enrollment: 130
Study Start Date: January 2008
Study Completion Date: July 2010
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: I
JACTAX LD DES
Device: JACTAX LD DES
Drug Eluting Stent
Active Comparator: II
TAXUS™ Libertè™ DES
Device: TAXUS™ Libertè™ DES
Drug Eluting Stent

Detailed Description:

The JACTAX Drug Eluting Stent has been designed to minimize the amount of polymer in contact with the vessel surface, thus potentially reducing the incidence of untoward side effects. The Juxtaposed Ablumenal Coating Process is capable of exclusive coating on the ablumenal side of pre-mounted bare metal stents. Juxtaposed Ablumenal Coating is a proprietary formulation containing a bioerodable polymer. The combination of the Juxtaposed Ablumenal Coating Process and Juxtaposed Ablumenal Coating create a unique microstructure surface, and reduces the amount of required polymer.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

General Inclusion Criteria:

  1. Patient is ≥ 18 years of age
  2. Patient with coronary artery disease, eligible for percutaneous coronary intervention (PCI)
  3. Patient demonstrates a LVEF of ≥ 25%
  4. Patient or legal guardian understands and agrees to comply with all specified study requirements and provides written informed consent to this effect.

Angiographic Inclusion Criteria

  1. Target lesion is de novo native coronary artery lesion (i.e., a coronary lesion not previously treated)
  2. The target lesion can be treated with a maximum of one stent, with adequate coverage onto the healthy tissue, as specified in visual estimate guidelines. Maximum lesion length is 20mm.
  3. The reference vessel diameter is between 2.75mm and 3.5mm
  4. Study lesion diameter stenosis is ≥70% (visual estimate) and <100% and a TIMI flow >1.
  5. Study lesion has been successfully pre-dilated
  6. Patients enrolled for treatment may demonstrate multiple lesions in target vessel. However lesions must be covered completely by one study stent.
  7. Patient must have no more than two lesions requiring treatments. These lesions must be in different vessel distributions. For example, if the target lesion is in the LAD, then the non target lesion must be present in either the circumflex or RCA. The non-study lesion may not be in a branch vessel or distal to the target vessel location.
  8. The non target lesion must be successfully treated prior to the treatment of the target lesion. The non target lesion must be treated with a TAXUS paclitaxel eluting stent or a bare metal stainless steel stent.

General Exclusion Criteria:

  1. The patient has a life expectancy of less than 24 months due to another medical condition
  2. Patient has a history of hypersensitivity to paclitaxel or structurally related compounds
  3. Patient exhibits cardiogenic shock (systolic pressure <80mmHg and PCWP >20mmHg or cardiac index <1.8 liters/minute/m or intra-aortic balloon pump or intravenous inotropes are needed to maintain a systolic pressure >80mmHg) for any time within 24 hours prior to index procedure
  4. Patient demonstrates evidence of acute or chronic renal dysfunction (serum creatinine >2.0 mg/dl or 177 umol/l)
  5. Planned cardiac surgery procedure <= 9 months post index procedure
  6. Patient demonstrates evidence of myocardial infarction (elevated CK, CKMB or Troponin) within 72 hours prior to the index procedure and/or CK >2X local lab's ULN, unless CK-MB is < 2X ULN
  7. Patient exhibits acute ST segment elevation MI within 72 hours prior to the index procedure
  8. CVA including stroke or TIA within previous 3 months
  9. Patient demonstrates evidence of leukopenia
  10. Patient demonstrates evidence of thrombocytopenia or thrombocytosis
  11. Patient is contraindicated to ASA, clopidogrel or ticlopidine
  12. Patient is currently taking warfarin or possibility of treatment with warfarin during the following 6 months post index procedure
  13. Patient has been treated with paclitaxel or other chemotherapeutic agents within 12 months prior to planned index procedure
  14. Anticipated treatment with paclitaxel or oral rapamycin during any period in the 9 months after the index procedure
  15. Patient has received a drug eluting stent within 12 months prior to planned index procedure
  16. Previous or planned treatment with intravascular brachytherapy in target vessel
  17. Known allergy to stainless steel
  18. Male or female with known intention to procreate within 3 months after the index procedure
  19. Female of childbearing potential with a positive pregnancy test within 7 days before the index procedure or lactating or intends to become pregnant during the 9 months post index procedure

Angiographic Exclusion Criteria

  1. Evidence of probable or definite thrombus of the study vessel, based on angiography or IVUS
  2. Study lesion is totally occluded (TIMI flow <= 1)either at baseline or before predilatation
  3. Study lesion or the study vessel proximal to the study lesion is moderately or severely calcified by visual estimate
  4. Study lesion is ostial in location (within 3.0 mm of vessel origin)
  5. Study lesion involving arterial segments with highly tortuous anatomy or where lesion is located within or distal to a > 60 degree bend in the vessel
  6. Study lesion involves a bifurcation with a diseased (>50% stenotic) branch vessel >2.0 mm in diameter
  7. Left main coronary artery disease (stenosis >50%) whether protected or unprotected
  8. Target lesion length >20mm based on visual estimate by operator
  9. Target vessel diameter >3.5mm based on visual estimate by operator
  10. Target vessel diameter <2.75 mm based on visual estimate by operator
  11. Pre-treatment of the target lesion (excluding predilation) with another interventional device
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00754975

Locations
Germany
Universitatsklinikum Bonn
Bonn, Germany
Cardiovascular Center Sankt Katharinen
Frankfurt, Germany
Hamburg University CardioVascular Center
Hamburg, Germany
HELIOS Klinikum
Siegburg, Germany
Krankenhaus der Barmherzigen Bruder
Trier, Germany
Sponsors and Collaborators
Boston Scientific Corporation
Labcoat, Ltd.
Investigators
Principal Investigator: Eberhard Grube Elizabeth Hospital, Essen Germany
  More Information

No publications provided

Responsible Party: Alison Osattin/Program Manager, Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT00754975     History of Changes
Other Study ID Numbers: LBCT-H02-07
Study First Received: September 16, 2008
Last Updated: August 5, 2010
Health Authority: Germany: Ethics Commission

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Heart Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on November 19, 2014